The combination of dabrafenib and trametinib received accelerated FDA approval for treating adult and pediatric patients, aged 6 and older with unresectable or metastatic solid tumors with a BRAF V600E mutation. This approval is for cases where the disease has progressed after prior treatment and no satisfactory alternative treatments are available, excluding colorectal cancer due to inherent resistance. The approval was based on positive results from studies BRF117019, NCI-MATCH, and CTMT212X2101, along with supporting results from previous melanoma and lung cancer trials. The studies demonstrated objective responses in 41% of 131 adults and 25% of 36 pediatric patients, with response durations varying according to tumor types.
The recommended dosage for adults is dabrafenib at 150 mg twice daily and trametinib at 2 mg once daily, with pediatric doses adjusted based on body weight, as specified in the product labeling. The treatments come with warnings and precautions for a range of potential issues, highlighting the importance of careful monitoring and management of patients undergoing this therapy.
Reference: Stenger M. Dabrafenib in Combination With Trametinib for Unresectable or Metastatic Solid Tumors With BRAF V600E Mutation. The ASCO Post. Published December 10, 2022. Accessed April 5, 2024. https://ascopost.com/issues/december-10-2022/dabrafenib-in-combination-with-trametinib-for-unresectable-or-metastatic-solid-tumors-with-braf-v600e-mutation/
